intellectual property rights and pharmaceutical industry
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Intellectual Property Rights and Pharmaceutical Industry. Drug Development Process and Importance of Intellectual Property Rights for R&D Industry. Increasing Challenges in The Pharmaceutical Industry. Increasing R&D costs High innovation pressure - PowerPoint PPT PresentationTRANSCRIPT
ABCDBoehringer Ingelheim Austria GmbH
Intellectual Property Rights and Pharmaceutical Industry
Drug Development Process and Importance of Intellectual Property Rights for R&D Industry
ABCDBoehringer Ingelheim Austria GmbH
Bratislava, 16.5.2000 Ch. Farniok 2
Increasing Challenges in The Pharmaceutical Industry
• Increasing R&D costs • High innovation pressure• Many more therapeutic targets to be explored and
utilized as drug intervention sites
ABCDBoehringer Ingelheim Austria GmbH
Bratislava, 16.5.2000 Ch. Farniok 3
Costs of Drug R&D
Research 47 million US$
Preclinical phase 38 million US$
Clinical phase 1 9 million US$
Clinical phase 2 24 million US$
Clinical phase 3 103 million US$
Registration 19 million US$
Total 240 million US$
ABCDBoehringer Ingelheim Austria GmbH
Bratislava, 16.5.2000 Ch. Farniok 4
Number of New Approved Drugs as Compared to Total R&D Expenditure of the Pharmaceutical Industry
05
10152025
303540455055
1989 1990 1991 1992 1993 1994 1995 1996 1997 1998
Number of new approved drugs
R&D expenditures in US$ bn
Inspite of increasing R&D expenditure, the number of new approved drugs remains relatively constant!
ABCDBoehringer Ingelheim Austria GmbH
The Future of Drug Discovery
The future of drug discovery depends on understanding the genetic basis of the disease.
ABCDBoehringer Ingelheim Austria GmbH
Bratislava, 16.5.2000 Ch. Farniok 6
1900 1950 1970 1990
Traditional drugs from plants
Enzymes
Receptors
Recombinant Drugs
Genomics Gene Therapy
Technological Advancements in Pharma ResearchTechnological Advancements in Pharma Research
ABCDBoehringer Ingelheim Austria GmbH
Bratislava, 16.5.2000 Ch. Farniok 7
The Change of Paradigm in Pharmaceutical R&D
• Classical R&D Approach
• Known lead structure for symptomatic therapy
• Optimization of active substance in animal model
• Clinical trial. Safety and efficacy
• Registration
• New R&D Approach
• Genetic cause of the disease (Genomics)
• Rational selection of the active substance (molecular genetics)
• High Throughput Screen • Optimization of active
substance with recombinant human gene products and combinatorial chemistry
• Clinical trial. Safety and efficacy
• Registration
ABCDBoehringer Ingelheim Austria GmbH
Bratislava, 16.5.2000 Ch. Farniok 8
Products of R&D
• Classical
• NCEs
• Vaccines bacterial extracts
• Proteins from animal tissue
• New
• NCEs (obtained by using genetic engineering technology)
• Non-infectious vaccines obtained by genetic engineering
• NBEs (recombinant human proteins, monoclonal antibodies)
• Gene Therapy
ABCDBoehringer Ingelheim Austria GmbH
Bratislava, 16.5.2000 Ch. Farniok 9
Known Molecular Processes Leading to Cancer
ABCDBoehringer Ingelheim Austria GmbH
Bratislava, 16.5.2000 Ch. Farniok 10
Steps in the NCE Discovery Process
primaryactivityscreens
functionalscreens
in vivo models
Early Discovery (exploratory) Late Discovery
Disease TargetIdentification
AssayDevelopment
LeadIdentification
LeadOptimization
unmetmedicalneed
commercialopportunity
protein orgeneinvolvedin disease-relatedpathologicalpathways
chemicalstarting point
optimizedcompound
DevelopmentCandidate
ABCDBoehringer Ingelheim Austria GmbH
Bratislava, 16.5.2000 Ch. Farniok 11
Gene Technology/Genomics
Robotic Screening (HTS)
Rational Design
Information Technology
Disease Target Assay LeadDevelopment Candidate
Combinatorial Chemistry
The New Core Technologies Influence Each Step of The Drug Development Process
ABCDBoehringer Ingelheim Austria GmbH
Bratislava, 16.5.2000 Ch. Farniok 12
Why patent?
ABCDBoehringer Ingelheim Austria GmbH
Bratislava, 16.5.2000 Ch. Farniok 13
Good Reasons for Patenting
• Patents prevent others from commercially utilizing an invention.
• For the research-based industry, periods of market exclusivity are crucial for the recoupment of R&D expenditure.
• Patents encourage financial risk and long-term research.
• Patents guarantee the dissemination of information.
ABCDBoehringer Ingelheim Austria GmbH
Bratislava, 16.5.2000 Ch. Farniok 14
What is a Patent?Which Rights Does a Patent Confer?
• A patent is a limited monopoly granted in respect of an invention.
• A patent confers the right to exclude others from making, using or selling the invention.
• This right is granted to the inventor (or his/her successor in title) by a national or regional authority.
• This right is limited in terms of territory and duration.
• The scope of this right is defined by the patent claims.
ABCDBoehringer Ingelheim Austria GmbH
Bratislava, 16.5.2000 Ch. Farniok 15
Which Rights Does a Patent Not Confer?
• A patent does not confer the "positive" right to use the invention!
• The use of an invention, whether patented or not, is subject to other national laws and regulations!
ABCDBoehringer Ingelheim Austria GmbH
Bratislava, 16.5.2000 Ch. Farniok 16
The Patent Right is Limited With Regard to Territory and Term
• Territorial scope :• National patents - both granting procedure and
effect are national
• European patents - the granting procedure is European, the effect is national
• International patent applications (PCT): the application and examination procedure is international, the granting procedure is European/national, the effect is national
• Term • 20 years from filing
ABCDBoehringer Ingelheim Austria GmbH
Bratislava, 16.5.2000 Ch. Farniok 17
Categories of Patent Claims
• Product
• Method
• Use
• Broadest protection. It covers all uses of the product, even those not explicitly disclosed.
• The protection for a method of manufacture also covers the products obtained by that method.
• Relatively narrow scope of protection - second medical use
ABCDBoehringer Ingelheim Austria GmbH
Bratislava, 16.5.2000 Ch. Farniok 18
Gene Technology/Genomics
Robotic Screening (HTS)
Rational Design
Information Technology
Disease Target Assay LeadDevelopment Candidate
Combinatorial Chemistry
The New Technologies of the R&D Process are Sources of Inventions
ABCDBoehringer Ingelheim Austria GmbH
Bratislava, 16.5.2000 Ch. Farniok 19
Patentable Inventions Created During the R&D Process
Research Toolstarget genes
screening assays reagents
cDNAs, ESTsanimal models
ABCDBoehringer Ingelheim Austria GmbH
Bratislava, 16.5.2000 Ch. Farniok 20
Patentable Inventions Created During the R&D Process
Drug (NCE or NBE)per semethod of makingformulationcombinationnovel use (second indication)
drug delivery system gene therapy
ABCDBoehringer Ingelheim Austria GmbH
Bratislava, 16.5.2000 Ch. Farniok 21
Telmisartan - a Boehringer Ingelheim Success Story - Part I
Xmas 1990Angiotensin
receptor antagonist
Telmisartan synthesized
February 1991
Priority patent
application
31.1.1992foreign filings
May 98European patent for Telmisartan
granted*
*in additon, several manufacturing and processing patent applications filed
ABCDBoehringer Ingelheim Austria GmbH
Bratislava, 16.5.2000 Ch. Farniok 22
Telmisartan - a Boehringer Ingelheim Success Story - Part II
Xmas 1998Registration of
TelmisartanEuropean Market
Authorization
June 1999SPC filed
Xmas 2013SPC expiry
January 2012Expiry ofEuropean
Patent